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Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs)
SOP ID Number: JBRU/SPON/S21/01 Effective Date: 01/04/2010 Version Number & Date of Authorisation: V01,15/03/2010 Review Date: 01/04/2012 eDocument kept: S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S21 SOP
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ACRONYMS: JBRU Joint Biomedical Research Unit http://www.ucl.ac.uk/joint-rd-unit

GCP Good Clinical Practice SOP Standard Operating Procedure CI Chief Investigator PI Principal Investigator TMF Trial Master File ISF Investigator Site File MHRA Medicines and Healthcare Products Regulatory Agency MREC Main Research Ethics Committee QA Quality Assurance Revision Chronology: SOP ID Number: Effective Date: Reason for Change: Author: JBRU/SPON/S21/01 15/02/10 Dave Wilson
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Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs)
1. PURPOSE
This Standard Operating Procedure (SOP) has been written to describe the procedure for the archiving of essential documents relating to the management of clinical trials of investigational medicinal products (CTIMPs) as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] and in accordance with local UCL policy on records retention, management and archiving.

2. JOINT UCLH/UCL BIOMEDICAL RESEARCH UNIT POLICY

All SOPs produced from the JBRU must be used in conjunction with local NHS Trust and UCL policies and procedures. The JBRU acts as the representative of the Sponsor and will be the official name used on all SOPs.

3. BACKGROUND
All SOPs are written in accordance with applicable GCP requirements as outlined in Directives 2001/20/EC and 2005/20/EC (in the UK, these Directives were transposed into UK law by SI 2004/1031, SI 2006/1928) and subsequent amendments and where applicable incorporates elements of ICH GCP tripartite guidelines (E6)" The EU GCP Directive 2005/28/EC and subsequent enabling legislation sets out the standard for archiving clinical trials essential documentation. As public funded CTIMPs need to meet UK regulatory standards set by the appropriate competent authority the Medicines and Healthcare products Regulatory Agency (MHRA), it is necessary for there to be a robust an secure archiving system to be in place for all essential documentation managed by the JBRU at the end of the life of a CTIMP. Archiving requires a systematic storing of a large volume of trial related documentation at a safe and protected repository that meets professional archiving standards and adheres to the Data Protection Act 1998. Historically and up to early 2010 the terminology used in the JBRU was the following: 1. The CIs file was called the site file. 2. The JBRUs file was called the Trial Master File TMF. However in 2010, the JBRU reviewed the terminology and it was agreed that as all JBRU UCL sponsored trials are investigator led trials, the CI is in fact holding the TMF and the JBRU is holding the JBRU sponsor file. If the trial is multisite, each site has a site file. All SOPs will be amended by the end of 2010 to reflect this change in terminology.

4. SCOPE OF THIS SOP

This SOP covers the archiving of essential documents held on paper and electronic Trial Master Files (TMFs) for CTIMPs sponsored by UCL and managed by the JBRU. Moving forward, using the new terminology, these electronic TMFs should be called electronic JBRU Sponsor Files Archiving covers both paper and electronic records. It does not cover records management systems. Essential documents are defined as
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documents which individually and collectively permit the evaluation of the data produced and are stored in the Trial Master File so that the clinical trial can be effectively reconstructed for audit and monitoring purposes. The list of essential trial documents to be archived is shown in Appendix 1 and is taken from the Trial Master File Index. Further details as to the operation of the UCL Archiving System is shown in Appendix 2. UCL Records Management Service (How to transfer records) is replicated in Appendix 3.

5. RESPONSIBLE PERSONNEL
The Database & Information Officer (DIO) is responsible for the archiving of all documents relating to CTIMPs within the JBRU. The responsible archivist for UCL is the UCL Records and Freedom of Information Officer based within UCL Records Office. The JBRU is responsible for presenting the paper JBRU sponsor file to the DIO for archiving. The named archivist for UCL is Mr Colin Penman (UCL Records Officer).

6. PROCEDURE
Storage and archiving To ensure that results from CTIMPs can be examined and subject to internal and regulatory audit, it is necessary that both Sponsor and Chief Investigator keep records of the clinical trial throughout its life cycle at site that are capable of being archived. Archiving of investigator site files as part of a multi-centre CTIMP will be determined by local site guidance and policy. A paper TMF is ready for archiving when the Chief Investigator of a CTIMP informs the JBRU that End of Trial Study Report has been submitted to the MHRA. This report is

required within one year of formal notification of end of Clinical Trial to Research Ethics Committee and MHRA. All essential documents held within the JBRU Sponsor file are appropriately archived through the transfer of records to the UCL Records Office using the Records Office Database in Citrix Program Neighbourhood. Records are stored securely at UCL s external archiving repository based at Wickford in Essex. A log of documents archived is kept within UCL Records Office. Electronic Data Archiving Electronic JBRU sponsor files are created and stored in a shared network S: Drive within the JBRU. The drive is only accessible by UCL employees within the JBRU. An Archive folder has been created within the S: Drive (S: /CLINICAL_TRIALS/TMFs_CTIMPs/TMF-Archived) where electronic JBRU sponsor files will be stored having been declared ended and when the corresponding paper JBRU sponsor file has been archived. UCL Records Management Policy is outlined online at http://www.ucl.ac.uk/efd/recordsoffice/policy/ . Retention Policy The EU GCP Directive 2005/28/EC states that essential documents should be retained for a minimum of 5 years after completion of the trial. In accordance with UCL Records Management Policy, research findings will need to be stored by UCL as sponsor for 20 years after the research has finished based on recommendations made in the Medical Research Councils Ethics Series on Good Clinical Practice. This deemed a sufficient period of time to allow for audit and inspections by regulatory authorities. The UCL Records Office provides a service to UCL staff and maintains archived records in a safe and secure off site location. All activities are conducted in accordance with the Data Protection Act and UCL Data Protection Policy. Access to the data is strongly
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regulated and permissions to access the data are treated case by case. The Records Office allows for records to be catalogued onto an online database, and assists in recalling archives on demand. Chief investigator TMF. It is the responsibility of the Chief Investigator to archive his/her TMF using the UCL archiving facilities. He/she will carry out a TMF review using the TMF review template and email this document to the JBRU together with the document detailing where his/her file has been archived. This document will be kept in the JBRU sponsor file section 18. Investigator Site File In a multi-centre clinical trial it will be the responsibility for each investigator site to arrange its own archiving of CTIMP records in paper and electronic form, in accordance with local policy and guidelines. Sponsor oversight of the content of the site file is captured as part of the end of trial SOP file. Pharmacy file Pharmacies will be responsible for arranging their own pharmacy file archiving. The Principal Investigator will have a file note in the Investigator Site File outlining where the trial Pharmacy file is archived. For both investigator site file and Pharmacy site file, the Principal Investigator will email the Chief Investigator to let him know where his files have been archived.

7. REFERENCES
Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] Section 8 of ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996) Medical Research Council Ethics Series on Good Clinical Practice EU GCP Directive 2005/28/EC

 Data Protection Act 1998 REFERENCED GUIDES / SOPs All SOPs, Policies, Procedures and Guidance produced by JBRU UCL Records Policy

http://www.ucl.ac.uk/joint-rd-unit
COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

8. APPENDICES
Appendix 1: List of Essential Documents in the JBRU sponsor file, CI Trial Master File http://www.ucl.ac.uk/joint-rd-unit Appendix 2: UCL Records Office Archiving System (Citrix Program Neighbourhood)
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1) To logon to Archive Database Enter the following URL in web browser: www.ucl.ac.uk/management-systems/msapps/otheradminsystems [This link takes you into UCL Information Services Division - Management Services]. Click onto live system (not old version) [MS log on & GEN 2) Procedure for archiving Login using normal IS username and IS p/w Records Office - Departmental users - Clients data entry takes you into Data Entry screen Click New Box [Cursor will be at reference and be yellow in colour]. Put in reference (format UCLH R&D BOX xxx) [taken from archives feeder spreadsheet maintained by Chris Lord] Click into File title Enter UCLH ID and Title [again from spreadsheet] Tip: To copy titles, use Ctrl C and Ctrl V to cut and paste from s/sheet to Data entry screen. Enter File type by clicking grey square and selecting 2 (Research) from the drop down list [this will apply only for the first record of each new box only] Click ok From Dateand Last Date put current month/year in the example format Oct-2008 Press F10 and OK to save record. Note that: Item number will now be saved. Box No reference will be automatically generated by the system (e.g. UCLH/2008/93).It is THIS reference that is written on the side of the archive box under Box No. before shipping to UCL Records Office. To go to second item within the same Box reference: Press green + sign to add a record [note that Item no. automatically changes to next consecutive number].
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Repeat process until all projects listed on s/sheet under the relevant box number reference, have been entered up onto records system. Annotate the feeder spreadsheet with the automatic generated Box No. reference. ______________________________________________________________ To enter a brand NEW Record (i.e. a new box) Click New Box and repeat stages as above. 3) Making changes to saved entries 2.1 Enter query by clicking the ? icon in the tool box [Box number field goes green] 2.2 Enter the auto-generated UCLH archive reference e.g.UCLH/2008/188 2.3 Press F8 to bring up record 2.4 Make changes by clicking into field (normally this is ever going to be the title field) 2.5 Press F10 to save changes -------------------------------------------------------------------------------------4) Checking entries made Repeat process above up to 2.3 Click into title field Use the forward blue forward arrow in the tool bar to go through records entered for given Box no. If any entries need amending, make changes and press F10 Go to next Box no. Legend: F10 = Execute F8 = Query F4 = Brings back previous record Ctrl C copies record from spreadsheet Ctrl V pastes record into archives system (name?) Location WD is entered by UCL Records Office and contained in the Box List prepared and sent to JBRU by UCL Records Office + green = new record Appendix 3 UCL Records Management Service, How to transfer Records
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The Records Office provides the Records Management Services for the whole of UCL. The Records Management Policy, which was confirmed as a UCL Policy in 1999, applies to all administrative records, whatever their format: http://www.ucl.ac.uk/efd/recordsoffice/policy/ All Institutes, Departments and Schools within UCL are expected to consult the Records Manager before disposing of non-current records. Please follow these simple guidelines every time you want to transfer your department's records to the Records Office. This will help us to help you to manage your records correctly. There is no charge for use of this service. Using the Database We control management of records through the Records Office database. You can describe your records on this database whenever you want to make a transfer. When you contact us we will check that you have signed up to the database. If not, we will arrange to provide you an account, give you access, and arrange training. The training module provides technical detail on how to operate the system. It will also provide instruction on what information should be held. Method of Storage Please use the boxes supplied by the Records Office for transferring your records. We supply these as flat packs free. Please contact the Records Office to request the

number of boxes you need. We use 2 box types: CAS 5 - Transfer File Box This is our standard Document Box with an Integral Lid. 360mm (L) x 140mm (H) x 255mm (W) Weight limit: 8 kg. or in special circumstances and only after agreement with the Records Office: CAS 4 - Archive Box Treble Wall Thickness Heavyweight & Secure 380mm (L) x 260mm (H) x 280mm (W) Weight limit: 10 kg. Packing the boxes Be careful not to overfill the box and keep the handles clear. Weight limits: We have been advised by the Library Services Health and Safety Officer that the weight limit for boxes should be as follows:
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SOP on Archiving JBRU/SPON/S21/01 Page 9 of 12 o Small CAS5 boxes must not weigh more than 8kg. o Large CAS4 boxes must not weigh more than 10kg.

Please note: 1. These limits are also necessary to meet the weight limits of the shelves in the library store. 2. Over weight boxes will be returned to the user department for repacking. Ring binders can be wasteful of space and, ideally, should not be put into boxes. Please remove the contents and put them into a file wallet, carefully writing the title and dates of the file on the outside. Please print off a box list and put it into the box. Please write the box no generated from the database system onto the box. We will give them the full numbers in the Records Office. Storage of items other than paper: Please advise the Records Office that you are intending to store items other than paper, such as electronic material or photographic material in the boxes provided. We can advise you of any issues that may need to be addressed. We will also ensure that the boxes are stored in a suitable area to protect the media. Collection When you have completed listing and packing your records, please telephone the Records Office and we will arrange for the College Porters to collect the boxes and bring them to the Records Office for checking. At the checking stage, we may find some boxes are badly packed or too heavy. In such cases we will contact you to find a way to resolve the situation. N.B. Please DO NOT contact the Estates & Facilities Help Desk for collection. This must be arranged with the Records Office. Records Office Administration On arrival in the Records Office we check the contents of the boxes against the data entered into the database and issue identifying department and shelf numbers, for the store. We then print off a box list with the full references and post it to the department. Please check that you have received a box list for every box that you have deposited and that the information is correct. It is your responsibility to contact the Records Office immediately if there is a discrepancy. Records Retrieval

The database training module will instruct you how to retrieve records from storage. The requested records will be returned to the Records Office by 2pm on the following working day. You will be notified as soon as the records arrive. We would prefer that you collect the records in person, but if you're unable to do this please call us and we can make alternative arrangements. If you wish to retain items retrieved permanently, please advise the Records Office so we can update the database. Destruction Policy All records should be retained or disposed of according to UCL retention schedules and appraisal guidelines established by the Records Management Programme. These are published separately and copies can be obtained from the Records Manager. When a box is sent to the Records Store a retention period is assigned to the box. The Records Office will contact you when the retention period has been
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reached to obtain approval to destroy the records. No records will be destroyed without your approval. Other Services: Short Term Storage In special circumstances and only after agreement with the Records Office, we can accommodate items into the Records Management Service for short-term storage, (eg: up to two years), while Departments are relocated. The standard guidelines for transfer of records to the store must be adhered to. Contacts at the Records Office All Record Office staff can provide you with general advice. Our collective mailbox is: records.office@ucl.ac.uk. Contacts: Wendy Butler x 32065 or w.butler@ucl.ac.uk Robert Winckworth x 32063 or r.winckworth@ucl.ac.uk

9. TEMPLATES/LOGS ASSOCIATED TO THIS SOP

1 Appendix 1 List of Essential Documents in the JBRU sponsor file, CI Trial Master File http://www.ucl.ac.uk/joint-rd-unit 2 Appendix 2 Operation of the UCL Archiving System (Citrix Program Neighbourhood) http://www.ucl.ac.uk/joint-rd-unit 3 Appendix 3 UCL Records Management Service How to transfer records http://www.ucl.ac.uk/joint-rd-unit

10. SOP DISSEMINATION AND TRAINING

New SOPs will be distributed to the concerned staff, by the named author on the front page of the SOP. Staff concerned by the SOP will sign the SOP training log (12. SOP TRAINING LOG) which is part of each SOP. In addition, each staff should have an Individual Staff SOP and courses log (template available in the http://www.ucl.ac.uk/jointrdunit website) and will need to update it once trained on the SOP. The training will constitute of the person reading the SOP and being provided with the opportunity to ask specific questions to the author of the SOP. The website link to JBRU SOPs is sent to the investigators as soon as the JBRU is aware of the trial being set up. The website link to new SOPs relevant to JBRU staff and investigators or investigators only will be emailed to the investigators by the author of the SOP. The investigators will be requested to read the new SOP and email back to acknowledge receipt and understanding of the new SOP. The email sent to the investigators and their emails acknowledging receipt and understanding of the SOP should be printed out and filed in the JBRU SOP folder together with the relevant SOP.
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11. SIGNATURE PAGE

Author and Job Title: Dave Wilson Database & Information Officer Signature: Date: Authorised by: Name and Job Title Helen Cadiou, Quality Assurance Manager Signature: Date:
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12. SOP TRAINING LOG

Name of Staff (Capital letters)
Job Title: Department: Training Date

I confirm that I understand & agree to work to this SOP

SIGNATURE Name of Trainer (if training required) Signature Date 1 2 3 4 5 6 7